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How may Rubraca help maintain the response to platinum-based chemotherapy?

Rubraca maintenance therapy was studied in a clinical trial of 564 women

Rubraca was evaluated in women whose ovarian cancer had come back and were in response to their second or later platinum-based chemotherapy. Of the women enrolled in the trial, 375 women were given 600 mg of Rubraca twice a day, and 189 women were given placebo twice a day.

Median* time to disease progression was 10.8 months for women treated with Rubraca and 5.4 months for women treated with placebo

The goal of maintenance therapy is to help maintain the response to chemotherapy and delay disease progression.

*Median is the middle point in a range of numbers, half of which are above the middle point and half of which are below it.

INDICATIONS

What is Rubraca?

Rubraca® (rucaparib) tablets are a prescription medicine used for:

the maintenance treatment of adults with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer whose cancer has come back and who are in response (complete or partial response) to a platinum-based chemotherapy

the treatment of adults with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have certain “BRCA” gene mutations, either inherited (germline) or acquired (somatic), and who have been treated with 2 or more chemotherapy medicines for their cancer. Your healthcare provider will perform a test to make sure Rubraca is right for you

It is not known if Rubraca is safe and effective in children.

SELECT IMPORTANT SAFETY INFORMATION

Rubraca tablets may cause serious side effects including bone marrow problems called Myelodysplastic Syndrome (MDS) or a type of cancer of the blood called Acute Myeloid Leukemia (AML).Some people who have ovarian cancer and who have received previous treatment with chemotherapy or certain other medicines for their cancer have developed MDS or AML during or after treatment with Rubraca. MDS or AML may lead to death. If you develop MDS or AML, your healthcare provider will stop treatment with Rubraca.

Symptoms of low blood cell counts are common during treatment with Rubraca but can be a sign of serious problems, including MDS or AML. Tell your healthcare provider if you have any of the following symptoms during treatment with Rubraca:

weakness

weight loss

fever

frequent infections

blood in urine or stool

shortness of breath

feeling very tired

bruising or bleeding more easily

Your healthcare provider will do blood tests before, and every month during treatment with Rubraca to monitor your blood cell counts. Weekly blood tests will be performed if you have low blood cell counts for a long time. Your healthcare provider may stop treatment with Rubraca until your blood cell counts improve.

Before you take Rubraca, tell your healthcare provider about all of your medical conditions, including if you:

are pregnant or plan to become pregnant. Rubraca can harm your unborn baby and may cause loss of pregnancy (miscarriage). You should not become pregnant during treatment with Rubraca.

If you are able to become pregnant, your healthcare provider may do a pregnancy test before you start treatment with Rubraca.

Females who are able to become pregnant should use effective birth control during treatment and for at least 6 months after receiving the last dose of Rubraca.

Talk to your healthcare provider about birth control methods that may be right for you.

Tell your healthcare provider right away if you become pregnant.

are breastfeeding or plan to breastfeed. It is not known if Rubraca passes into breast milk. Do not breastfeed during treatment and for 2 weeks after the last dose of Rubraca. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

While taking Rubraca, avoid spending time in sunlight. Rubraca can make your skin sensitive to the sun (photosensitivity). You may burn more easily during treatment with Rubraca. You should wear a hat and clothes that cover your skin and use sunscreen to help protect against sunburn if you have to be in the sunlight.

The most common side effects of Rubraca include:

nausea

tiredness or weakness

vomiting

decrease in hemoglobin (anemia)

changes in how food tastes

constipation

decrease in appetite

diarrhea

low blood cell counts

mouth sores

upper respiratory tract infection

shortness of breath

rash

changes in liver or kidney function blood tests

stomach (abdomen) pain

increased cholesterol levels

These are not all of the possible side effects of Rubraca. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects.

You may report side effects to the FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch. You may also report side effects to Clovis Oncology, Inc. at 1‑415‑409‑7220 (US toll) or 1‑844‑CLVS‑ONC (1‑844‑258‑7662; US toll-free).

Please see full Prescribing Information, including Patient Information, for additional Important Safety Information.

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INDICATIONS

What is Rubraca?

Rubraca® (rucaparib) tablets are a prescription medicine used for:

the maintenance treatment of adults with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer whose cancer has come back and who are in response (complete or partial response) to a platinum-based chemotherapy

the treatment of adults with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have certain “BRCA” gene mutations, either inherited (germline) or acquired (somatic), and who have been treated with 2 or more chemotherapy medicines for their cancer. Your healthcare provider will perform a test to make sure Rubraca is right for you

It is not known if Rubraca is safe and effective in children.

SELECT IMPORTANT SAFETY INFORMATION

Rubraca tablets may cause serious side effects including bone marrow problems called Myelodysplastic Syndrome (MDS) or a type of cancer of the blood called Acute Myeloid Leukemia (AML).Some people who have ovarian cancer and who have received previous treatment with chemotherapy or certain other medicines for their cancer have developed MDS or AML during or after treatment with Rubraca. MDS or AML may lead to death. If you develop MDS or AML, your healthcare provider will stop treatment with Rubraca.

Symptoms of low blood cell counts are common during treatment with Rubraca but can be a sign of serious problems, including MDS or AML. Tell your healthcare provider if you have any of the following symptoms during treatment with Rubraca:

weakness

weight loss

fever

frequent infections

blood in urine or stool

shortness of breath

feeling very tired

bruising or bleeding more easily

Your healthcare provider will do blood tests before, and every month during treatment with Rubraca to monitor your blood cell counts. Weekly blood tests will be performed if you have low blood cell counts for a long time. Your healthcare provider may stop treatment with Rubraca until your blood cell counts improve.

Before you take Rubraca, tell your healthcare provider about all of your medical conditions, including if you:

are pregnant or plan to become pregnant. Rubraca can harm your unborn baby and may cause loss of pregnancy (miscarriage). You should not become pregnant during treatment with Rubraca.

If you are able to become pregnant, your healthcare provider may do a pregnancy test before you start treatment with Rubraca.

Females who are able to become pregnant should use effective birth control during treatment and for at least 6 months after receiving the last dose of Rubraca.

Talk to your healthcare provider about birth control methods that may be right for you.

Tell your healthcare provider right away if you become pregnant.

are breastfeeding or plan to breastfeed. It is not known if Rubraca passes into breast milk. Do not breastfeed during treatment and for 2 weeks after the last dose of Rubraca. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

While taking Rubraca, avoid spending time in sunlight. Rubraca can make your skin sensitive to the sun (photosensitivity). You may burn more easily during treatment with Rubraca. You should wear a hat and clothes that cover your skin and use sunscreen to help protect against sunburn if you have to be in the sunlight.

The most common side effects of Rubraca include:

nausea

tiredness or weakness

vomiting

decrease in hemoglobin (anemia)

changes in how food tastes

constipation

decrease in appetite

diarrhea

low blood cell counts

mouth sores

upper respiratory tract infection

shortness of breath

rash

changes in liver or kidney function blood tests

stomach (abdomen) pain

increased cholesterol levels

These are not all of the possible side effects of Rubraca. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects.

You may report side effects to the FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch. You may also report side effects to Clovis Oncology, Inc. at 1‑415‑409‑7220 (US toll) or 1‑844‑CLVS‑ONC (1‑844‑258‑7662; US toll-free).

Please see full Prescribing Information, including Patient Information, for additional Important Safety Information.